Cl ll Becton Dickinson Phoenix”

Company:Becton Dickinson & Co..
Date of Enforcement Report 6/6/12
Class ll:

PRODUCT
1) Becton Dickinson Phoenix” System Software, catalog # 448035/448046, component of BD automated microbiology system, and used with BD Gram Positive MIC or MIC/ID panels. Product Usage: Automated Microbiology System for the quantitative determination of antimicrobial susceptibility by minimal inhibitory concentration (MIC) of Gram Positive bacteria from pure culture. Recall # Z-1657-2012;

2) Becton Dickinson Phoenix” Update Disks (PUD), catalog # 441107/ 448047, component of BD automated microbiology system, and used with BD Gram Positive MIC or MIC/ID panels. Product Usage: This update disk was an interim corrective action recommended by FDA to be installed in Phoenix instruments so that test results associated with E.faecium susceptibility can not be printed by the labs until a final algorithm correction (change) is implemented by the firm. BD Phoenix” Update Disks (PUD). Recall # Z-1658-2012

REASON
In vitro diagnostics manufacturer identified an increase in vancomycin-resistant strains that may exhibit erroneous results on all PMIC or PMIC/ID panels and could lead to ineffective treatment regimen in affected patients.

RECALLING FIRM/MANUFACTURER
Becton Dickinson & Co., Sparks, MD, by letter dated April 18, 2012. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
3,454,993 units

DISTRIBUTION
Nationwide and Internationally

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About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

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